International Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis (ALTO)

April 15, 2016 updated by: Stallergenes Greer

An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.

The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.

Study Overview

Status

Terminated

Conditions

Detailed Description

Primary objective:

To describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass pollen season in real-life settings.

Secondary objectives:

- To describe the patient's perceived effectiveness of ORALAIR® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication

Study Type

Observational

Enrollment (Actual)

740

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antony, France, 92183
        • Laboratoire Stallergenes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with allergic rhino-conjunctivitis are visiting their allergist during grass-pollen season when symptoms are strong. In accordance with the terms of the Marketing Authorization, ORALAIR® treatment has to be set-up "at the right moment" about 4 months before the next grass-pollen season.

Description

Inclusion Criteria:

  • Patient of 5 years of age and older at the date of the screening visit
  • Patient with proven allergic rhino-conjunctivitis due to grass pollen
  • Patient eligible for a grass-pollen Allergen ImmunoTherapy (AIT)
  • Patient whose physician prescribed ORALAIR® independently of the study, before the beginning of the grass-pollen season

Exclusion Criteria:

  • Patient participating in a clinical trial or in an epidemiological study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
allergic rhino-conjunctivitis
Patient with proven allergic rhino-conjunctivitis due to grass pollen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: patients will be followed for the duration of the treatment, an expected average of 6 months/year
The primary objective is to describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass-pollen season in real-life settings.
patients will be followed for the duration of the treatment, an expected average of 6 months/year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Effectiveness
Time Frame: patients will be followed for the duration of the treatment, an expected average of 6 months/year
To describe the patient's perceived effectiveness of ORALAIR® in allergic rhino-conjunctivitis management in terms of disease intensity, satisfaction and rescue medication
patients will be followed for the duration of the treatment, an expected average of 6 months/year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stallergenes Greer

Collaborators

Registrat-Mapi

Investigators

  • Principal Investigator: Alain DIDIER, MD, Hôpital Larrey, Toulouse, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORA-PES-05-WO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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